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Effects of Long-Term Administration of Human Albumin in Subjects With Decompensated Cirrhosis and Ascites (PRECIOSA)

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ClinicalTrials.gov Identifier: NCT03451292
Recruitment Status : Recruiting
First Posted : March 1, 2018
Last Update Posted : March 13, 2019
Sponsor:
Collaborator:
Instituto Grifols, S.A.
Information provided by (Responsible Party):
Grifols Therapeutics LLC

Tracking Information
First Submitted Date  ICMJE February 12, 2018
First Posted Date  ICMJE March 1, 2018
Last Update Posted Date March 13, 2019
Actual Study Start Date  ICMJE July 24, 2018
Estimated Primary Completion Date October 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 23, 2018)
Time to liver transplantation or death (whichever comes first) through 1 year after randomization in subjects receiving SMT + Albutein 20% administration versus subjects receiving SMT alone [ Time Frame: 12 months ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03451292 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: February 23, 2018)
  • Time to liver transplantation or death (whichever comes first) through 3 months after randomization in subjects receiving SMT + Albutein 20% administration versus subjects receiving SMT alone [ Time Frame: 3 months ]
  • Time to liver transplantation or death (whichever comes first) through 6 months after randomization in subjects receiving SMT + Albutein 20% administration versus subjects receiving SMT alone [ Time Frame: 6 months ]
  • Time to death through 3 months after randomization in subjects receiving SMT + Albutein 20% administration versus subjects receiving SMT alone [ Time Frame: 3 months ]
  • Time to death through 6 months after randomization in subjects receiving SMT + Albutein 20% administration versus subjects receiving SMT alone [ Time Frame: 6 months ]
  • Time to death through 1 year after randomization in subjects receiving SMT + Albutein 20% administration versus subjects receiving SMT alone [ Time Frame: 12 months ]
  • Total number of paracenteses through 1 year after randomization in subjects receiving SMT + Albutein 20% administration versus subjects receiving SMT alone [ Time Frame: 12 months ]
  • Total number of incidences of refractory ascites according to the International Club of Ascites (ICA) through 1 year after randomization in subjects receiving SMT + Albutein 20% administration versus subjects receiving SMT alone [ Time Frame: 12 months ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Effects of Long-Term Administration of Human Albumin in Subjects With Decompensated Cirrhosis and Ascites
Official Title  ICMJE Prevention of Mortality With Long-Term Administration of Human Albumin in Subjects With Decompensated Cirrhosis and Ascites
Brief Summary This is a phase 3, multicenter, randomized, controlled, parallel-group, and open-label clinical study to evaluate the efficacy of standard medical treatment (SMT) + Albutein 20% administration versus SMT alone in subjects with decompensated cirrhosis and ascites. The study population will consist of subjects being discharged after hospitalization for acute decompensation of liver cirrhosis with ascites (or with prior history of ascites requiring diuretic therapy) with or without acute-on-chronic liver failure (ACLF) at admission or during hospitalization but without ACLF at discharge.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Decompensated Cirrhosis and Ascites
Intervention  ICMJE
  • Drug: Albutein 20% Injectable Solution
    Within 96 hours after discharge and following randomization, subjects will receive the first Albutein 20% infusion at the dose of 1.5 g/kg body weight (maximum 100 grams per subject). Thereafter, subjects will receive Albutein 20% infusions at the dose of 1.5 g/kg body weight (maximum 100 grams per subject) every 10 ± 2 days for the rest of the study (up to a maximum of 12 months). Subjects in this treatment group will also receive SMT.
  • Other: Standard medical treatment
    Subjects will receive SMT according to published guidelines for the management of decompensated cirrhosis.
Study Arms  ICMJE
  • Experimental: SMT + Albutein 20%
    Interventions:
    • Drug: Albutein 20% Injectable Solution
    • Other: Standard medical treatment
  • Active Comparator: SMT
    Intervention: Other: Standard medical treatment
Publications * Fernández J, Clària J, Amorós A, Aguilar F, Castro M, Casulleras M, Acevedo J, Duran-Güell M, Nuñez L, Costa M, Torres M, Horrillo R, Ruiz-Del-Árbol L, Villanueva C, Prado V, Arteaga M, Trebicka J, Angeli P, Merli M, Alessandria C, Aagaard NK, Soriano G, Durand F, Gerbes A, Gustot T, Welzel TM, Salerno F, Bañares R, Vargas V, Albillos A, Silva A, Morales-Ruiz M, Carlos García-Pagán J, Pavesi M, Jalan R, Bernardi M, Moreau R, Páez A, Arroyo V. Effects of Albumin Treatment on Systemic and Portal Hemodynamics and Systemic Inflammation in Patients With Decompensated Cirrhosis. Gastroenterology. 2019 Jul;157(1):149-162. doi: 10.1053/j.gastro.2019.03.021. Epub 2019 Mar 22.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: February 23, 2018)
410
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE October 2021
Estimated Primary Completion Date October 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Subjects with diagnosis of liver cirrhosis and uncomplicated ascites according to the ICA criteria
  • Subjects being discharged after hospitalization for acute decompensation of liver cirrhosis with ascites (or with prior history of ascites requiring diuretic therapy) with or without ACLF at admission or during hospitalization but without ACLF at discharge
  • Subjects with ongoing diuretic treatment with an anti-mineralocorticoid drug at a dose of ≥100 mg/day and furosemide ≥40 mg/day independent of response to treatment
  • In subjects with cirrhosis due to hepatitis B virus, decompensation must occur in the setting of continuous (not <3 months) appropriate antiviral therapy
  • In subjects with cirrhosis due to hepatitis C virus, only decompensated patients who will not receive antiviral therapy during the study period will be included
  • In subjects with cirrhosis due to autoimmune hepatitis, decompensation must occur in the setting of continuous immunosuppressive therapy

Exclusion Criteria:

  • Subjects with ongoing ACLF at discharge
  • Subjects with ongoing or recent (within the last 30 days) hepatorenal syndrome (HRS), infection, or bleeding complications
  • Subjects with transjugular intrahepatic portosystemic shunt (TIPS) or other surgical porto-caval shunts
  • Subjects with an established diagnosis of refractory ascites as defined by ICA criteria
  • Subjects requiring ≥2 paracenteses during the previous 30 days
  • Subjects receiving anti-platelet therapy or anti-coagulant therapy during the previous 30 days
  • Subjects with ongoing endoscopic eradication of esophageal varices at discharge
  • Subjects with hepatic encephalopathy grade III or IV
  • Subjects with evidence of current locally advanced or metastatic malignancy. Subjects with hepatocellular carcinoma within the Milan criteria, non-melanocytic skin cancer, or controlled breast or prostate cancer can be included
  • Subjects with chronic heart failure
  • Subjects with severe (grade III or IV) pulmonary disease
  • Subjects with serum creatinine >2.0 x upper limit of normal
  • Subjects with organic nephropathy as defined by ICA criteria
  • Subjects with sever psychiatric disorders
  • Subjects with a known infection with human immunodeficiency virus (HIV) or have clinical signs and symptoms consistent with current HIV infection
  • Females who are pregnant, breastfeeding, or if of childbearing potential, unwilling to practice a highly effective method of contraception throughout the study
  • Subjects with previous liver transplantation
  • Subjects with known or suspected hypersensitivity to albumin
  • Subjects participating in another clinical study within 3 months prior to screening
  • Subjects with active drug addiction
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Mireia Torres +34 93 5712273 mireia.torres@grifols.com
Contact: Ed Corsi +1 9193166222 Ed.Corsi@grifols.com
Listed Location Countries  ICMJE Belgium,   Denmark,   Germany,   Italy,   Spain,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03451292
Other Study ID Numbers  ICMJE IG1601
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Grifols Therapeutics LLC
Study Sponsor  ICMJE Grifols Therapeutics LLC
Collaborators  ICMJE Instituto Grifols, S.A.
Investigators  ICMJE Not Provided
PRS Account Grifols Therapeutics LLC
Verification Date March 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP